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The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LID022821, then AOHP | Other | Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. |
|
| AOHP, then LID022821 | Other | Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serafilcon A contact lenses | Device | Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity With Study Lenses at Week 1 Follow-Up | Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint. | Week 1, each wear period. A wear period was approximately 14 days. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CDMA Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drs. Giedd, PA | Maitland | Florida | 32751 | United States | ||
| Wesley Optometric Consulting |
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This reporting group includes all enrolled participants/eyes (68/136).
Participants were recruited from 5 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | LID022821, Then AOHP | Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. |
| FG001 | AOHP, Then LID022821 | Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, Approximately 14 Days |
| |||||||||||||
| Period 2, Approximately 14 Days |
|
Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LID022821, Then AOHP | Serafilcon A contact lenses worn during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity With Study Lenses at Week 1 Follow-Up | Visual acuity (VA) was assessed with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set. | Posted | Mean | Standard Deviation | logMAR | Week 1, each wear period. A wear period was approximately 14 days. | eyes | eyes |
|
Adverse Events (AE's) were collected from time of consent to study exit, approximately 28 days.
AE's were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE's is reported in units of eyes; all other populations are reported in units of subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | Events reported in this group occurred prior to exposure to the study contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2022 | Aug 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2022 | Aug 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| Senofilcon A contact lenses | Device | Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily cleaning and disinfection |
|
|
| CLEAR CARE | Device | Hydrogen peroxide based contact lens cleaning and disinfecting solution |
|
|
| Medina |
| Minnesota |
| 55340 |
| United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| NOT COMPLETED |
|
| BG001 | AOHP, Then LID022821 | Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. The serafilcon A contact lenses were replaced with a fresh pair at the Week 1 follow-up visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG001 | AOHP | Senofilcon A contact lenses worn during Period 1 or Period 2, as randomized, in both eyes at least 10 hours per day for approximately 14 days. CLEAR CARE was used for daily cleaning and disinfection. |
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | LID022821 Ocular | Events reported in this group occurred while exposed to the serafilcon A contact lenses | 0 | 136 | 0 | 136 | 0 | 136 |
| EG002 | LID022821 Non-Ocular | Events reported in this group occurred while exposed to the serafilcon A contact lenses | 0 | 68 | 0 | 68 | 0 | 68 |
| EG003 | AOHP Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses | 0 | 136 | 0 | 136 | 0 | 136 |
| EG004 | AOHP Non-Ocular | Events reported in this group occurred while exposed to the senofilcon A contact lenses | 0 | 68 | 0 | 68 | 0 | 68 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.